Royal Pharmaceutical Society of Great Britain, London
Thursday 5 March 2009
09.30 Registration and coffee
10.00 Introduction Dr Ray Munden, Chairman, Joint Pharmaceutical Analysis Group
10.05 Quality of clinical trial applications Dr Elaine Godfrey and Dr Martin O’Kane, Pharmaceutical Assessors, Clinical Trials Unit, MHRA, UK 10.55 CTD five years on: an industrial perspective Dr Julie L Williams, Pfizer,UK 11.30 Common inspection findings on IMP sites Richard Funnell, Senior MHRA Inspector, Inspection Division, MHRA 12.05 Experiences of an IMP QP at an IMP outsource provider Paul Graham, Quality Director, SCM Pharma Ltd 12.40 Lunch, Exhibition and Poster viewing ** 13.40 39th Annual General Meeting for JPAG members 14.10 Experiences of an IMP Qualified Person at a big pharma R & D siteDr Eva-Maria Borchert, R&D Quality and Compliance Northern Europe Regional Manager, Sanofi-Aventis 14.45 MCRN presentation on the provision of CT suppliesTony Nunn, Associate Director, Medicines for Children Research Network, University of Liverpool 15.20 The sponsor’s experience Speaker to be confirmed 15.55 Panel discussion Speakers and invited panellists 16.25 Closing remarks Dr Ray Munden 16.30 Close
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